Newborn Bovine Calf Serum - Gamma Irradiated
We source NBS from audited suppliers within the US. Our NBS is manufactured and processed according to the highest standards and is carefully monitored to ensure product safety and performance. These standards are built in to RMBIO's entire supply chain. After filtration and filling, the NBS is gamma irradiated at an industry standard dose of 25-40kGy.
- Average endotoxin level*: < 2 EU/ml (specification = ≤ 35 EU/ml)
- Average hemoglobin level*: < 20 mg/dl (specification = < 30 mg/dL)
- 9CFR tested
- 0.2 µm filtered
- Gamma irradiated at a dose of 25-40kGy
- Manufactured at GMP compliant and FDA registered facility
- Standard newborn calf serum packaged in 500mL or 1 L bottles. Custom packages are also available.
- Storage conditions: ≤ -10° C
*Data based on last 10 lots produced.
Gamma Irradiation 101
Gamma irradiation is a physical inactivation approach used to achieve pathogen reduction in the serum. This mitigates risk from low-level contaminants that may not be detected through viral or mycoplasma testing. RMBIO serum is gamma irradiated via controlled exposure to Cobalt 60 at an industry standard dose of 25-40kGy. Most typical viral contaminants of bovine serum are readily inactivated at this irradiation range. Advantages of gamma irradiation include:
- No potential for residual contaminants
- Widely accepted by pharmaceutical and research industries
- Accepted by regulatory agencies
- Minimal effect on product performance
- Effective virus inactivation
Newborn Calf Serum specific product test requirements and typical values are given below:
Parameter | Method | Specification |
---|---|---|
Total Protein | Chemistry Analyzer | 3.0 - 6.5 g/dL |
Osmolality | By Osmometer | 240 - 360 mOsm/Kg |
pH | pH Meter | 6.5 - 8.5 |
Hemoglobin | Spectro. Assay | < 30 mg/dl |
Endotoxin | LAL | ≤ 35 EU/ml |
Sterility, Mycoplasma, and Viral Analysis | 9CFR 113.26, 28, 53 | Tested |
Electrophoretic ID | Gel Electrophoresis | Characteristic |
Other Parameters | Comprehensive Chemistry Testing | As Reported |
Gamma Irradiation | 25-40kGy |
Parameter | Method | Specification |
---|---|---|
Total Protein | Chemistry Analyzer | 3.0 - 6.0 g/dL |
Osmolality | By Osmometer | 240 - 360 mOsm/Kg |
pH | pH Meter | 6.5 - 8.5 |
Hemoglobin | Spectro. Assay | < 30 mg/dl |
Endotoxin | LAL | ≤ 35 EU/ml |
Sterility, Mycoplasma, and Viral Analysis | 9CFR 113.26, 28, 53 | Tested |
Electrophoretic ID | Gel Electrophoresis | Characteristic |